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Device | ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | Boston Scientific Corp. TWO SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P900056 |
Supplement Number | S043 |
Date Received | 03/17/2000 |
Decision Date | 04/11/2000 |
Product Code |
MCX |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a quality control change that increases the number of times the burr size is verified or measured during the manufacturing process. |